Ignite Creation Date:
2024-05-06 @ 1:05 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03922841
Status:
COMPLETED
Last Update Posted:
2021-10-01
First Post:
2019-04-17
Brief Title:
Pleural Disease Phenotypes Diagnostic Yield and Outcomes
Sponsor:
Singapore General Hospital
Organization:
Singapore General Hospital
Study Overview
Official Title:
Pleural Disease Phenotypes Diagnostic Yield and Outcomes
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pleural disease ie with effusions or pneumothorax have a high disease burden to patients This is because most patients require diagnostic and therapeutic interventions in the form of drainage and biopsies With increasing age the incidence of pleural disease is likely to rise with concomitant rise in pulmonary malignancy and infection
The impact of pleural disease especially ambulatory drainage depends not only on patient factors such as effusion size cardiopulmonary co-morbidities and underlying aetiology It also depends on socioeconomic factors such as ability to afford ambulatory equipment which is not covered by Medisave availability of care-givers and coping mechanisms
To phenotype patients presenting to Singapore General Hospital with pleural disease and evaluate impact on outcomes of pleural interventions
This study will collect existing or prospective data that is part of standard clinical care
Source of the data electronic medical record of patients ambulatory and inpatient
Data will be collected prospectively
The impact of pleural disease especially ambulatory drainage depends not only on patient factors such as effusion size cardiopulmonary co-morbidities and underlying aetiology It also depends on socioeconomic factors such as ability to afford ambulatory equipment which is not covered by Medisave availability of care-givers and coping mechanisms
To phenotype patients presenting to Singapore General Hospital with pleural disease and evaluate impact on outcomes of pleural interventions
This study will collect existing or prospective data that is part of standard clinical care
Source of the data electronic medical record of patients ambulatory and inpatient
Data will be collected prospectively
Detailed Description:
1 BACKGROUND AND RATIONALE
Pleural disease ie with effusions or pneumothorax have a high disease burden to patients This is because most patients require diagnostic and therapeutic interventions in the form of drainage and biopsies With increasing age the incidence of pleural disease is likely to rise with concomitant rise in pulmonary malignancy and infection
The impact of pleural disease especially ambulatory drainage depends not only on patient factors such as effusion size cardiopulmonary co-morbidities and underlying aetiology It also depends on socioeconomic factors such as ability to afford ambulatory equipment which is not covered by Medisave availability of care-givers and coping mechanisms
Therefore translating internationally accepted pleural interventions into an Asian context moreover a Singaporean one is challenging
2 HYPOTHESIS AND OBJECTIVES
Asian patients with pleural disease have unique phenotypes and outcomes from pleural interventions
To phenotype patients presenting to Singapore General Hospital with pleural disease and evaluate impact on outcomes of pleural interventions
3 EXPECTED RISKS AND BENEFITS
There are likely to be no benefits to subjects They will not be subject to any novel therapy and their clinical data will only be collected
Risks are minimal because patients are subject to only standard therapy and existing clinical data collected There will be no new additional interventions consultations or hospital visits They will be asked to complete validated quality of life surveys that will be included into the clinical record
4 STUDY POPULATION
41 List the number and nature of subjects to be enrolled
Patients will only be enrolled from those who present to Singapore General Hospital either in an ambulatory or inpatient setting There is no exclusion of women children or minorities although clinical catchment includes mostly adult patients
42 Criteria for Recruitment and Recruitment Process
Subjects will be recruited if they already have radiographic evidence of pleural disease
43 Inclusion Criteria
The subject must meet all of the following inclusion criteria to participate in this study
1 Evidence of pleural disease on chest radiograph or bedside ultrasound or Computed Tomography regardless of underlying aetiology
2 No age or gender restrictions
3 Ability to provide informed consent
44 Exclusion Criteria Subjects who no radiographic evidence of pleural disease or who are unwillingunable to provide informed consent
5 STUDY DESIGN AND PROCEDURESMETHODOLOGY
This study will collect existing or prospective data that is part of standard clinical care
Source of the data electronic medical record of patients ambulatory and inpatient
Data will be collected prospectively
Time period March 2018-2023
When subject collection is complete the data will be de-identified and kept in an electronic database
Only principal investigator and co-investigators will have access to collected information
Data be kept for 5 years after completion of study for data analysis and manuscript preparation
All electronic copies of data will be destroyed at the end of the study All manual records if any will be shredded
Data that will be collected
Demographic data such as age gender ethnicity
Clinical data such as co-morbidities medication history American Society of Anaesthesiologists ASA status smoking history functional status eg ECOG
Radiographic data including effusion size septations nodularity underlying emphysemafibrosisconsolidationmalignancy
Laboratory data Serum and pleural LDH glucose albumin total protein Full blood counts Renal panel Liver Panel Coagulation studies
Histopathology and microbiology results
Procedure Pleural tapcatheter insertionbiopsy details designation of operator procedure duration anaesthesia used complications volume of effusion drained number of biopsies taken location of procedure anti-microbials pleurodesis
Outcome measures such as radiographic improvement duration of pleural catheter quality of life using standardized measures eg St Georges Respiratory Questionnaire survival hospital re-admission further procedures needed eg interventional radiology or thoracic surgery
Subjects may withdraw voluntarily from participation in the study at any time They will have standard care as indicated by the managing physician
6 SAFETY MEASUREMENTS 61 Definitions
An adverse event AE is any untoward medical occurrence that occurs as a result of the study This will reported to CRIB
62 Collecting Recording and Reporting of Adverse Events and Serious Adverse Events to CIRB
PI will be responsible for submitting to the approving CIRB the completed serious AE Reporting Form within 7 calendar days after the investigator is aware of the event followed by a complete report within 8 additional calendar days AE that are related events should be reported at least annually together with Study Status Report for annual review
63 Safety Monitoring Plan
Not applicable Current standard investigations and treatment to be provided to all subjects
64 Complaint Handling
Complaints about the study will be escalated to the clinical Head of Department and included in reports to the CIRB
7 DATA ANALYSIS
71 Data Quality Assurance
Data collection will be done by the investigators through the clinical team managing the patient to ensure completion and accuracy
72 Data Entry and Storage
Data will be entered and stored in a secure web application REDCappassword controlled hospital computer When subject data collection is complete the data will be de-identified and kept in an electronic database password secured for analysis Only investigators will have access to the data
There are no plans to keep any documentation of patients beyond the informed consent forms These will be stored in the locked department office of the investigators
8 SAMPLE SIZE AND STATISTICAL METHODS
81 Determination of Sample Size
The sample size is determined by the number of patients accrued into the database during the study period As this is a non-comparative study study size calculation not applicable
82 Statistical and Analytical Plans
Continuous safety analyses tracking for AE
Interim Analyses of data on an annual basis
9 DIRECT ACCESS TO SOURCE DATADOCUMENTS
The CRIB will be permitted to audit the database as needed Source documents are from electronic medical records
10 QUALITY CONTROL AND QUALITY ASSURANCE
Data collection will be done by the investigators through the clinical team managing the patient to ensure completion and accuracy
11 ETHICAL CONSIDERATIONS
111 Informed Consent
Informed consent will be sought from the patient or legal guardian in the case of minors by the study investigators before any data collection is done
112 Confidentiality of Data and Patient Records
Data will be entered and stored in a secure web application REDCappassword controlled hospital computer When subject data collection is complete the data will be de-identified and kept in an electronic database password secured for analysis Only investigators will have access to the data
There are no plans to keep any documentation of patients beyond the informed consent forms These will be stored in the locked department office of the investigators
Pleural disease ie with effusions or pneumothorax have a high disease burden to patients This is because most patients require diagnostic and therapeutic interventions in the form of drainage and biopsies With increasing age the incidence of pleural disease is likely to rise with concomitant rise in pulmonary malignancy and infection
The impact of pleural disease especially ambulatory drainage depends not only on patient factors such as effusion size cardiopulmonary co-morbidities and underlying aetiology It also depends on socioeconomic factors such as ability to afford ambulatory equipment which is not covered by Medisave availability of care-givers and coping mechanisms
Therefore translating internationally accepted pleural interventions into an Asian context moreover a Singaporean one is challenging
2 HYPOTHESIS AND OBJECTIVES
Asian patients with pleural disease have unique phenotypes and outcomes from pleural interventions
To phenotype patients presenting to Singapore General Hospital with pleural disease and evaluate impact on outcomes of pleural interventions
3 EXPECTED RISKS AND BENEFITS
There are likely to be no benefits to subjects They will not be subject to any novel therapy and their clinical data will only be collected
Risks are minimal because patients are subject to only standard therapy and existing clinical data collected There will be no new additional interventions consultations or hospital visits They will be asked to complete validated quality of life surveys that will be included into the clinical record
4 STUDY POPULATION
41 List the number and nature of subjects to be enrolled
Patients will only be enrolled from those who present to Singapore General Hospital either in an ambulatory or inpatient setting There is no exclusion of women children or minorities although clinical catchment includes mostly adult patients
42 Criteria for Recruitment and Recruitment Process
Subjects will be recruited if they already have radiographic evidence of pleural disease
43 Inclusion Criteria
The subject must meet all of the following inclusion criteria to participate in this study
1 Evidence of pleural disease on chest radiograph or bedside ultrasound or Computed Tomography regardless of underlying aetiology
2 No age or gender restrictions
3 Ability to provide informed consent
44 Exclusion Criteria Subjects who no radiographic evidence of pleural disease or who are unwillingunable to provide informed consent
5 STUDY DESIGN AND PROCEDURESMETHODOLOGY
This study will collect existing or prospective data that is part of standard clinical care
Source of the data electronic medical record of patients ambulatory and inpatient
Data will be collected prospectively
Time period March 2018-2023
When subject collection is complete the data will be de-identified and kept in an electronic database
Only principal investigator and co-investigators will have access to collected information
Data be kept for 5 years after completion of study for data analysis and manuscript preparation
All electronic copies of data will be destroyed at the end of the study All manual records if any will be shredded
Data that will be collected
Demographic data such as age gender ethnicity
Clinical data such as co-morbidities medication history American Society of Anaesthesiologists ASA status smoking history functional status eg ECOG
Radiographic data including effusion size septations nodularity underlying emphysemafibrosisconsolidationmalignancy
Laboratory data Serum and pleural LDH glucose albumin total protein Full blood counts Renal panel Liver Panel Coagulation studies
Histopathology and microbiology results
Procedure Pleural tapcatheter insertionbiopsy details designation of operator procedure duration anaesthesia used complications volume of effusion drained number of biopsies taken location of procedure anti-microbials pleurodesis
Outcome measures such as radiographic improvement duration of pleural catheter quality of life using standardized measures eg St Georges Respiratory Questionnaire survival hospital re-admission further procedures needed eg interventional radiology or thoracic surgery
Subjects may withdraw voluntarily from participation in the study at any time They will have standard care as indicated by the managing physician
6 SAFETY MEASUREMENTS 61 Definitions
An adverse event AE is any untoward medical occurrence that occurs as a result of the study This will reported to CRIB
62 Collecting Recording and Reporting of Adverse Events and Serious Adverse Events to CIRB
PI will be responsible for submitting to the approving CIRB the completed serious AE Reporting Form within 7 calendar days after the investigator is aware of the event followed by a complete report within 8 additional calendar days AE that are related events should be reported at least annually together with Study Status Report for annual review
63 Safety Monitoring Plan
Not applicable Current standard investigations and treatment to be provided to all subjects
64 Complaint Handling
Complaints about the study will be escalated to the clinical Head of Department and included in reports to the CIRB
7 DATA ANALYSIS
71 Data Quality Assurance
Data collection will be done by the investigators through the clinical team managing the patient to ensure completion and accuracy
72 Data Entry and Storage
Data will be entered and stored in a secure web application REDCappassword controlled hospital computer When subject data collection is complete the data will be de-identified and kept in an electronic database password secured for analysis Only investigators will have access to the data
There are no plans to keep any documentation of patients beyond the informed consent forms These will be stored in the locked department office of the investigators
8 SAMPLE SIZE AND STATISTICAL METHODS
81 Determination of Sample Size
The sample size is determined by the number of patients accrued into the database during the study period As this is a non-comparative study study size calculation not applicable
82 Statistical and Analytical Plans
Continuous safety analyses tracking for AE
Interim Analyses of data on an annual basis
9 DIRECT ACCESS TO SOURCE DATADOCUMENTS
The CRIB will be permitted to audit the database as needed Source documents are from electronic medical records
10 QUALITY CONTROL AND QUALITY ASSURANCE
Data collection will be done by the investigators through the clinical team managing the patient to ensure completion and accuracy
11 ETHICAL CONSIDERATIONS
111 Informed Consent
Informed consent will be sought from the patient or legal guardian in the case of minors by the study investigators before any data collection is done
112 Confidentiality of Data and Patient Records
Data will be entered and stored in a secure web application REDCappassword controlled hospital computer When subject data collection is complete the data will be de-identified and kept in an electronic database password secured for analysis Only investigators will have access to the data
There are no plans to keep any documentation of patients beyond the informed consent forms These will be stored in the locked department office of the investigators
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None